Quality Systems Specialist

About the role

The Quality Systems Specialist supports and maintains the Quality Management System (QMS) and oversees the creation, review, approval, revision, and controlled release of quality and technical product documentation including, but not limited to, validation guides, assembly component summaries, component attributes, specifications, validation and compliance documentation, certificates, and related quality records. The position works cross-functionally with internal teams including Quality, Engineering, R&D/NPI, Regulatory Compliance, Manufacturing, and Supply Chain, as well as external suppliers and customers, to ensure product information is accurate, complete, traceable, and compliant with established quality requirements.

Responsibilities

• Develop, compile, review, approve, revise, and maintain controlled quality and technical documentation, including SOPs, specifications, forms, validation guides, and related records.
• Coordinate the collection and verification of product and component information, including drawings, part numbers, materials, suppliers, manufacturers, compliance information, validation data, steril